Counterfeits of biotech drugs: a big trouble

February 29, 2012 8:29 AM

Everything started about two weeks ago. FDA issued letters to 19 Medical Practices about the fake, counterfeit versions of Avastin, the cancer drug which is widely used to treat several versions of cancers (1). 

The investigation continued and both FDA and the manufacturer of the product, Roche posted some information about the counterfeit versions of Avastin. Yesterday, Roche said that,  fake Avastin had salt, starch and chemicals but none of the life extending medicine or any other biotech drug (2).

Now, according to a news story from Reuters, we can see that, the counterfeit versions of Avastin had a long way before reaching the US market:

Fake versions of the multibillion-dollar cancer drug Avastin were purchased in Turkey before being traded by middlemen across the Middle East and Europe to the United States, an Egyptian businessman involved said on Tuesday.

Milad Kamal Ayad, who works on commission for Egyptian firm SAWA, told Reuters he sourced 167 packets of Avastin from Turkey, via a Syrian businessman also based in Egypt, for Swiss-based Hadicon AG.

The drug, found to be counterfeit, eventually reached clinics in California, Texas and Illinois. It contained no life extending medicine or any other biotech drug, Roche said on Monday, but instead contained salt, starch and a variety of chemicals.

The case involving Roche’s top-selling cancer treatments has underscored how even expensive injectable medicines, not just pills like Viagra and Lipitor, are at risk from criminal counterfeiters.

It also shows how difficult it is to trace the source of such counterfeits as they pass from one supplier to another.

“Via SAWA, I bought these items from a Syrian. Of course, I didn’t know they were counterfeit copies,” Ayad said, speaking in a meeting at the Reuters bureau in Cairo where he described the deal.

He said that a sample packet of the drug he was shown by the Syrian appeared to be original.

Phony Avastin has been found in the region previously. Roche said on Friday that fake versions of Avastin were discovered in Syria in 2009.

In the latest case, the U.S. distributor, known as Montana Healthcare Solutions, listed Avastin along with its Turkish name Altuzan on an order form obtained by Reuters.

It was not clear if the fake drug originated in Turkey.

Roche said there had been a number of other “individual cases” of counterfeit Avastin in the past few years, including a previously reported incident in Shanghai in 2010.

The phony Avastin was sold by Hadicon to Danish drug distributor CareMed, which shipped it on directly to Britain’s River East Supplies, according to Danish and British regulators.

An Egyptian Health Ministry official earlier said no company by the name SAWA was registered with the ministry to import or export drugs. Ayad said SAWA had a more general license to trade and said the shipment of drugs never entered Egypt.

Every shipment of Avastin or any other drug entering Egypt needs a Health Ministry license and is then subject to analysis before release, Yousef Ehab, Roche general manager in Egypt, told Reuters. Batches are also tracked after that, he added.

In addition, Ehab said contracts to import the drug include a clause preventing re-export, unless there are exceptional circumstances with a good reason. Even then, approval is needed from both Roche and the ministry, Ehab added.

Ehab said Roche was working with its customers and hospitals to ensure no counterfeit Avastin drugs were in use in Egypt.

Editor’s comment: As you can see from the short summary, the drug had a long way before reaching the US market and most of the middlemen were trusted suppliers. Counterfeiting is a serious problem for the industry and the numbers of counterfeits of expensive medicines are increasing every day.

From our point of view, this will be the same when biosimilars reach the market; biosimilars will expand the markets and counterfeit players will definitely try to find a way to enter those “exciting” areas. This is a big trouble for the industry and the health authorities and although some countries try to develop tracking systems, it’s not easy to track such a traffic which is described in the newsstory above.

Sources:
1: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm291968.htm
2: http://www.reuters.com/article/2012/02/28/us-fake-avastin-idUSTRE81R22H20120228
3: http://www.reuters.com/article/2012/02/28/us-egyptian-avastin-idUSTRE81R24120120228

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